Senior Associate Scientist/ Manager, Analytical Outsourcing (ONSITE OR REMOTE)United States - California - Foster City, United States – RemoteManufacturing Operations & Supply ChainRegular
Senior Associate Scientist/ Manager, Analytical Outsourcing (ONSITE OR REMOTE)
The Senior Associate Scientist/ Manager level position in Gilead’s Analytical Outsourcing organization will be responsible for managing analytical activities outsourced to third party contract laboratories (CTLs) and contract manufacturing organizations (CMOs). We are seeking candidates with working experience collaborating with outsourced testing laboratories with prior experience in biologics in a pharmaceutical development or quality control setting. This individual will be a key point of contact between Gilead and one or more external partners, responsible for the supplier relationship and performance management.
- Manages outsourced analytical and quality control testing activities for biologics bulk drug substance, drug products, and parenterals.
- Serves as the primary day to day contact to support the relationship between Gilead and assigned contract organizations.
- Develops strategy for management of outsourced testing needs, considering timelines, risk mitigation and business priorities.
- Develops, executes and ensures compliance to procedures for outsourced testing oversight.
- Coordinates with legal and quality assurance groups to establish confidentiality/nondisclosure agreements, service terms and conditions, and quality agreements.
- Reviews and facilitates approval of proposals, work orders, and changes of scope.
- Assists in transfer of new projects to various contract organizations.
- Coordinates testing schedules based on program requirements by interfacing with colleagues in Biologics, Analytical Operations and counterparts in Chemical Development and Formulation/Process Development.
- Monitors and troubleshoots key outsourced testing activities via email, teleconferences and site visits.
- Executes strategies that drive effective operational performance and service levels at contract organizations.
- Communicates risks and delays to management and technical leads on a timely basis.
- Participates in Quality audits as required.
- Supports strategic business and quality compliance processes and changes by participating in working groups and acting as business process owner for system changes as needed.
- Provides input for budgeting based on outsourced analytical needs.
- Negotiate and manage key CTL agreements (MSAs, SOWs, Supply Agreements, Pricing, etc.)
- Effectively communicate project, performance, and resource issues to management and project teams.
Knowledge & Skills:
- Ability to influence and work well with others in a proactive and constructive manner.
- Strong communication skills, both verbal and written, with all levels of an organization.
- An independent self-starter with the ability to resolve supplier performance challenges and implement process and/or system improvements.
- Proven ability to problem solve, build strong relationships, and to organize effectively.
- Business acumen with an ability to anticipate operational issues and proactively recommend mitigations/solutions.
- Demonstrated ability to multi-task and to work across multiple multi-national sites and diverse cultures
Education & Experience
- A Bachelor’s Degree and a minimum of seven (7) years of experience, OR a Master’s Degree with a minimum of five (5) years of experience OR a PhD.
- Experience with analytical/QC testing for large molecules/biologics.
- Direct experience managing supplier relationships and outsourced analytical/QC testing.
- Experience with parenteral and/or solid oral dosage forms.
If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.yello.co/external/form/24a8oU4jF5UL3CKq7lO_Cg
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.